Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 30, 2026 | Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722... | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 30, 2026 | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (72206... | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 24, 2026 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Nu... | Due to unintentionally activated near infrared handheld camera when attempting to turn off illumi... | Class II | Intuitive Surgical, Inc. |
| Mar 27, 2026 | Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO | Labeling update to provide warning if functionality of the valve replacement delivery system is ... | Class II | Edwards Lifesciences, LLC |
| Mar 24, 2026 | Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, ... | Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy de... | Class II | ICU Medical, Inc. |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extrav... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,K... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, ... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: TAV... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extrav... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: HEA... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 11, 2026 | Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, ... | ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 cath... | Class II | Medtronic, Inc. |
| Feb 25, 2026 | Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; ... | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... | Class II | Medline Industries, LP |
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-1... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-10... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-15... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-911... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-11... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP1... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Mod... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Ca... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Jan 23, 2026 | Claviculaplate with Angular Stability, with the below descriptions and associ... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 7, 2026 | Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) C... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2)... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) ... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130;... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 5, 2026 | Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI... | Due to a modification by a vendor and may be reinstalled without properly engaging the outside re... | Class II | Raz Design Inc |
| Dec 31, 2025 | Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET... | Under circumstances involving exposure to particular chemicals and mechanical forces, the male lu... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, ... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY,... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Materia... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Ma... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | Portex Spinal Tray, Item No. A3729-24 A3595 | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or re... | Class II | ICU Medical Inc. |
| Dec 19, 2025 | Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P... | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or re... | Class II | ICU Medical Inc. |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Materia... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: R... | Needle free access device intended as accessory to vascular access used in hemodialysis or access... | Class II | ICU Medical, Inc. |
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; ... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Mater... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Mat... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 18, 2025 | Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784... | Due to product that may contain a void in the material that separates the wire guide and cutting ... | Class II | Wilson-Cook Medical Inc. |
| Dec 15, 2025 | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | Presence of particulates in affected devices that can be deposited into breast tissue during use. | Class II | Hologic, Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.